RBW Consulting
Qualified Person
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Qualified Person (QP) – Aseptic Pharmaceuticals
Location: Manchester (Site-Based)
Hours: Full-time, with some early morning shifts
Salary: Competitive + excellent benefits package
About the Role
We are looking for an experienced Qualified Person (QP) to join an aseptic pharmaceutical manufacturing site in Stoke-on-Trent. This is an exciting opportunity to play a critical role in ensuring the safety, quality, and compliance of sterile medicinal products manufactured on-site.
As the QP, you will be responsible for the certification and release of batches in accordance with EU/UK GMP requirements. You’ll work closely with Quality, Production, Validation, and Regulatory teams, providing leadership and expert guidance to maintain the highest standards of aseptic control.
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Key Responsibilities
- Certify and release batches of aseptically manufactured products in line with Annex 16 and applicable regulations
- Ensure ongoing GMP compliance across production, quality systems, and the wider site
- Provide oversight and support during aseptic operations, media fills, and environmental monitoring activities
- Lead or support investigations, risk assessments, and deviation/CAPA management
- Contribute to continuous improvement initiatives and audit readiness
- Act as a key liaison during regulatory inspections and internal/external audits
- Offer expert QP advice to cross-functional teams
- Participate in early morning shifts as required to support aseptic operations
About You
- Eligibility to act as a Qualified Person under UK/EU Directive 2001/83/EC
- Some previous experience within aseptic/sterile manufacturing preferred
- Sound knowledge of MHRA/EMA requirements and GMP principles
- Excellent decision-making, problem-solving, and communication skills
- Collaborative, resilient, and comfortable working in a fast-paced regulated environment
- Able to work on-site full-time and support early morning activities when needed
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What’s on Offer
- Competitive salary and annual bonus
- 25+ days holiday plus bank holidays
- Private healthcare
- Professional development and continuous training
- A supportive, quality-driven culture with opportunities to influence and improve
How to Apply
If you’re a QP with a passion for aseptic manufacturing and want to make a real impact within a growing pharmaceutical site, we’d love to hear from you!
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